Just four weeks remain in the trading year, yet a number of key clinical readouts are still slated for release before the end of 2020. We list a selection below. Readers may also view our preview of PDUFA and other regulatory events, including FDA Advisory Committee meetings for two COVID-19 vaccine candidates, scheduled for December.
First, let’s review the week that was with price-moving events.
COVID-19 VACCINE:
Moderna, Inc. (NASDAQ:MRNA) shares closed the week up 20% to $152.52. The company announced further data from its COVID-19 vaccine Phase 3 trial of mRNA-1273 conducted on 196 cases, confirming high efficacy observed at the first interim analysis, indicating a vaccine efficacy of 94.1%. The data showed that all 30 severe cases of COVID-19 in the trial occurred in the placebo group with none occurring in the mRNA-1273 vaccinated group. The company also announced the submission to the FDA of a Emergency Use Authorization (EUA, which will be reviewed by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday, December 17.
Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) shares closed the week up 47% to $112.01. The company is in earlier Phase 1/2 development for its COVID-19 vaccine ARCT-021, which similar to Moderna and Biontech (BNTX) uses messenger RNA (mRNA) technology.
REGULATORY:
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced Thursday that the FDA approved oral, once-daily Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. Shares closed Friday up 19% to $6.10.
Minerva Neurosciences, Inc. (NASDAQ:NERV) shares closed Wednesday down 26% to $2.89 following the release of feedback from the FDA regarding its drug roluperidone, in development for patients with schizophrenia. Its Phase 3 trial failed to meet the primary endpoint earlier this year, and in its update, it noted:
“The FDA cautioned that an NDA submission based on the current data from the Phase 2b and Phase 3 studies would be highly unlikely to be filed and that, at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this indication.”
CLINICAL DATA:
Sutro Biopharma, Inc. (NASDAQ: STRO) shares closed Friday up 33% to $22.65 following the release of data from its Phase 1 trial of STRO-002 in patients with ovarian cancer. Of the 31 evaluable patients, 1 patient achieved a complete response (CR) and 9 patients achieved a partial response (PR) - 3 confirmed and 6 unconfirmed. 23 patients (74%) achieved disease control at 12 weeks, while 18 patients (58%) achieved disease control at 16 weeks.
Ovid Therapeutics Inc. (NASDAQ:OVID) shares fell Wednesday 56% to $2.94 following news its Phase 3 Neptune trial of OV101 (gaboxadol) for the treatment of Angelman syndrome did not meet the primary endpoint.
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Biotech clinical data readouts to watch in December: